FDA Faces Industry-Patient Divide on GenAI Regulation, Draft Policy Expected Soon
The U.S. Food and Drug Administration (FDA) has received 540 comments regarding its proposed regulatory framework for medical devices incorporating generative artificial intelligence (GenAI). A significant divide has emerged between industry stakeholders, who advocate for regulatory flexibility and lighter oversight, and patient advocacy groups, who demand stronger clinical evidence, transparency, and robust oversight. Industry groups like AdvaMed and the US Chamber of Commerce called for reliance on existing frameworks, greater use of Predetermined Change Control Plans (PCCPs), and increased postmarket monitoring. Wearables maker Oura specifically urged the FDA to exempt low-risk, informational GenAI features in consumer wearables from medical device regulation. Conversely, patient groups, including Pathway for Patient Health and the National Health Council, emphasized broader risk assessments, patient vulnerability, diverse clinical testing, and manufacturer accountability. Rick Abramson, director of the...
